Manufacturing Quality Manager – Medical Device

Overview

Lead quality initiatives for medical device manufacturing, ensuring regulatory compliance.

Key Responsibilities

• qc planning
• supplier audits
• process capability
• validation review
• capa management
• regulatory compliance

Tasks

As the Manufacturing Quality Manager, you’ll oversee product quality assurance, quality system management, and manufacturing process excellence—while playing a key role in resolving customer issues and advancing continuous improvement efforts. You’ll report directly to the International Director of Quality and collaborate with teams across manufacturing, engineering, and regulatory to uphold the highest standards of product safety and performance. This position supports compliance with FDA, ISO 13485, and international regulatory standards (EU, Canada, Brazil, Japan, and more), ensuring quality systems and operations align with global best practices. -Develop QC plans, sampling systems, and statistical controls. -Manage supplier quality, audits, and performance. -Maintain and communicate accurate project schedules. -Conduct internal, customer, and ISO audits per FDA/ISO requirements. -Champion quality goals, policies, and regulatory adherence. -Perform process capability studies and implement quality enhancements. -Maintain 510(k)s, DHFs, DHRs/DMRs, and validation records per FDA, ISO 13485, and global regulations. -Review and approve validation protocols, reports, and reliability data. -Lead CAPA and problem-solving to prevent and resolve quality issues. -Track corrective action effectiveness and drive continuous improvement. -Improve processes and systems to ensure cGMP and ISO 13485 compliance. -Support Manufacturing and R&D in risk management, qualification, and validation.

Requirements

• project management
• process optimization
• fda
• bs engineering
• gmp
• lean six sigma

What You Bring

-Proven project management and multitasking skills -Strong understanding of manufacturing inputs/outputs, materials, waste, cost control, and process optimization -Experience with FDA, ISO, and/or TS Quality Systems -BS in Engineering preferred; other technical or science degrees considered -In-depth knowledge of GMP, Quality Systems, Regulatory Requirements, Validation, and Manufacturing in a medical device environment -3+ years of Quality experience in Manufacturing Operations -Skilled in interpreting technical/scientific publications and regulatory documents; capable of writing reports and procedures and presenting to senior leadership or regulatory bodies -ASQ Quality Auditor/Engineer, PE, or Lean Six Sigma certification highly desirable

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Benefits

$95k to $100k plus bonus with solid benefits package.

About Morisey-Dart Group

-It began by placing leaders in residential, commercial, and heavy civil construction before branching out. -Typical projects include recruiting C-suite and senior executives for sectors like multi-family, healthcare, highways, MRO, and compliance. -Its precision-focused model emphasizes client consultation, market research, and tailored candidate matching. -Through targeted practice teams—from luxury homebuilding to federal construction—they deliver sector-specific expertise.

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